Senior Specialist, Raw Material Analytical Characterization

Merck; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Paid holidays and vacation

Job summary

Merck in the United States (Pennsylvania) seeks a scientist to lead analytical characterization and oversight of raw materials for biologics manufacturing. You will define CMAs, assess risk, engage suppliers, and ensure robust processes, product quality, and supply continuity.

You will develop analytical methods, apply orthogonal approaches, and collaborate across Manufacturing, Quality, Procurement, and Regulatory Affairs. GMP, USP/EP/QB standards apply; domestic relocation may be available.

Qualifications

• Bachelor’s degree with 6+ years of relevant experience; OR Master’s with 4+ years; OR Ph.D. with no industry experience.
• Experience in biopharmaceutical/biotechnology analytical sciences or materials characterization.
• Knowledge of GMP, regulatory expectations, and quality systems.

Responsibilities

• Lead raw material characterization programs for biologics manufacturing.
• Identify CMAs and assess impact on process performance and CQAs.
• Develop strategies to evaluate composition, purity, impurity profiles, stability, and lot variability.
• Collaborate with cross-functional teams to mitigate material-related risks.
• Support supplier qualification, technology transfers, and regulatory submissions.

Skills

Analytical chemistry

Data analysis

Cross-functional PM

Regulatory compliance

Technical transfer

Problem solving

Education

Bachelor’s in Analytical Chemistry/related

Master’s in Analytical Chemistry/related

Ph.D. in scientific field

Tools

HPLC

LC-MS

LC-MS/MS

GC-MS

ICP-MS

Job description

Position Summary

The Biologics Raw Materials team within Biologics Drug Substance & Commercialization (BDSC) is seeking a highly motivated scientist to lead analytical characterization and technical oversight of raw materials used in biologics manufacturing. This role will focus on understanding and controlling raw material variability through analytical characterization, risk assessment, and supplier engagement to ensure robust manufacturing processes, product quality, and supply continuity.

Key Responsibilities

Raw Material Characterization & Risk Assessment

• Develop raw material characterization program for raw materials used in biologics manufacturing, including cell culture media, feeds, amino acids, vitamins, trace elements, salts, and excipients.
• Identify and assess Critical Material Attributes (CMAs) and their impact on process performance, product quality, and Critical Quality Attributes (CQAs).
• Develop characterization strategies to evaluate composition, purity, impurity profiles, stability, and lot-to-lot variability.
• Investigate sources of raw material variation and work with process teams to better understand potential impact on cell growth, productivity, glycosylation, aggregation, potency, and product quality.
• Apply risk-based approaches to prioritize materials based on process impact, product quality risk, supplier performance, traceability, and supply chain complexity.
• Support qualification of new materials, suppliers, and alternate sourcing strategies.
• Strong knowledge of compendial methods and pharmacopeial standards (USP, EP, JP, BP), including their application to raw material testing and characterization. Demonstrated ability to evaluate, harmonize, and standardize test methods across compendial, supplier, and internal laboratories.

Analytical Characterization

• Develop analytical methods used for raw material characterization.
• Apply advanced analytical techniques to identify and quantify impurities, trace contaminants, degradation products, and supplier-to-supplier differences.
• Utilize orthogonal analytical approaches to generate comprehensive material characterization packages.
• Evaluate and implement innovative analytical technologies that improve understanding of raw material variability.

Cross-Functional & External Collaboration

• Partner with Manufacturing, Process Development, Quality, Procurement, Supply Chain, Regulatory Affairs, and external suppliers to assess and mitigate material-related risks.
• Support technology transfers, quality investigations, supplier assessments, and regulatory submissions.
• Communicate analytical findings, technical risks, and recommendations to scientific and business stakeholders.
• Collaborate with suppliers to improve raw material quality, consistency, transparency, and supply reliability.

Regulatory & Compliance Support

• Support regulatory filings, inspections, and agency responses through scientific assessments and analytical data packages.
• Ensure analytical methodologies align with GMP requirements and current regulatory expectations.
• Contribute to raw material control strategies consistent with ICH Q8, Quality by Design (QbD), and risk-based manufacturing principles.

Education And Experience

• Bachelor’s, Master’s, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, Materials Science, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline.
• Bachelor’s degree with 6+ years of relevant experience; OR Master’s degree with 4+ years of relevant experience; OR Ph.D. with no industry experience.
• Relevant experience may include biopharmaceutical, biotechnology, analytical sciences, materials characterization, process development, manufacturing support, or quality operations.

Required Skills

• Expertise in analytical chemistry, materials characterization, or biophysical characterization.
• Experience developing and applying analytical methods to characterize complex materials and sources of variability.
• Understanding of raw material variability and its impact on bioprocess performance and product quality.
• Strong scientific problem-solving, data interpretation, and investigation skills.
• Proven ability to lead scientific projects and collaborate across cross-functional teams.

Preferred Skills

• Experience with biologics manufacturing, cell culture, fermentation, purification, or aseptic processing.
• Understanding of chemically defined media and feed systems and their impact on cell performance and product quality.
• Experience characterizing impurities and trace-level contaminants affecting process performance or product quality.
• Expertise in chromatographic and mass spectrometry techniques, including HPLC, UPLC, UHPLC, LC-MS, LC-MS/MS, GC-MS, ICP-MS, and related methodologies.
• Experience with cell-based assays, amino acid/vitamin analysis, particle characterization, microscopy, thermal analysis, or other advanced characterization techniques.
• Experience using analytical data to support supplier qualification, raw material risk assessments, and supply chain optimization.
• Familiarity with PAT, automation, digital tools, and data analytics.
• Experience working with suppliers and external laboratories to improve raw material quality and consistency.

Key Competencies

Adaptability, Adaptability, Analytical Thinking, Bioprocess Understanding, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Cross-Functional Collaboration, Materials Characterization, Risk Analysis, Risk Assessments, Risk Control Assessment, Stakeholder Communications, Stakeholder Engagement

Required Skills:

Analytical Chemistry, Analytical Tools, Biologics, Characterization Techniques, Cross-Functional Project Management, Data Analysis Tools, Liquid Chromatography (LC), Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmaceutical Sciences, Raw Material Analysis, Raw Material Sourcing, Regulatory Compliance, Technical Transfer, Technology Transfer

US And Puerto Rico Residents Only

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Salary Range

The salary range for this role is $117,000.00 - $184,200.00

Bonus Eligibility

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Employee Status

Regular

Relocation

Domestic

Visa Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/29/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R417373